Common Terminology Criteria for Adverse Events

Cancer Therapy Evaluation Program (CTEP) developed the original Common Toxicity Criteria (CTC) in 1983 to aid in standardizing the description of adverse events (AEs) and grading the severity of those events for oncology clinical trials with therapeutic interventions. The CTC was revised twice. The Common Terminology Criteria for Adverse Events version 3 (CTCAEv3) was implemented in 2003 to provide: a list of AE terms commonly encountered in oncology; assist in the recognition and severity grading of AEs; standardize reporting of AEs across groups and treatment modalities; supply guidelines for protocol eligibility, Dose Limiting Toxicity, Maximum Tolerated Dose and dose modification; and monitor safety data to facilitate the evaluation of new therapies, treatment modalities and supportive measures.

CTEP and caBIG™ (Cancer Biomedical Informatics Grid) VCDE (Vocabulary and Common Data Elements) Workspace are revising the current version of CTCAE. The targeted completion date is early in 2009. The goals of the CTCAE project are:

• To better meet the needs of clinical investigators using CTCAE
• To harmonize CTCAE with MedDRA (the Medical Dictionary for Regulatory Activities)
• To revise and further describe adverse events and severity indicators in the terminology
• To conform to caBIG Vocabulary criteria
• To establish a formal, ongoing governance for future maintenance of CTCAE

The development of the CTCAE revision involves the participation of representatives of the National Cancer Institute, National Institutes of Health, academia, Food and Drug Administration, pharmaceutical companies and Cooperative Groups.